GastroparesisPhase 4NCT00390975
Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis
A Phase 4 study testing Tegaserod in people with Gastroparesis and Diabetes, run by Novartis at 3 sites in United States.
Trial summary
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroparesis, Diabetes
- What is being tested?
- Tegaserod
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2007to Mar 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females and males 18 to 75 years of age
- History of type I or type II diabetes mellitus for more than 3 years
- History of upper gastrointestinal symptoms consistent with diabetic gastroparesis
- Hemoglobin A1c < 9.5%
- Delayed gastric emptying
Who cannot join
- Abnormal endoscopy finding that can explain the presence of gastroparesis symptoms
- Medical conditions affecting gastric emptying
- A clinically significant medical condition that would interfere with the patient completing the trial
- Clinically significant abnormal creatinine level
- Known allergies to the same class of drug and/or allergies to eggs
- Severe obesity
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
The University of Kansas Medical Center
Kansas City, Kansas, 66160
The University of Louisville
Louisville, Kentucky, 40292
About this study
Official title: An Open-label Pilot Trial to Assess the Effect of Tegaserod on Improvement of Gastric Emptying in Patients With Diabetic Gastroparesis and Upper Gastrointestinal Symptoms
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.
- Conditions
- Gastroparesis, Diabetes
- Being tested
- Tegaserod
- Keywords
- Tegaserod, diabetes, diabetic gastroparesis, gastric emptying, gastric retention, electrogastrography
- Medical subject headings
- Gastroparesis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegaserodDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET)
Secondary outcomes (5)
Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying
Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort
Volume and symptomatic response to a gastric satiety drink test (GSDT)
Electrogastrography (EGG)
The safety and tolerability of tegaserod
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionMar 2007
- Study completionMar 2007
Why it stopped: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceutical Corporation, Study chair, NPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390975
- Sponsor's protocol ID
- CHTF919GUS62
- Status last verified
- May 2012
- First submitted
- 20 Oct 2006
- Last updated
- 4 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pilot Trial to Assess the Effect of Tegaserod on Improvement of Gastric Emptying in Patients With Diabetic Gastroparesis and Upper Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT00390975
- Acronym / sponsor ID
- CHTF919GUS62
- Conditions
- Gastroparesis, Diabetes
- Keywords
- Tegaserod, diabetes, diabetic gastroparesis, gastric emptying, gastric retention, electrogastrography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 23 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females and males 18 to 75 years of age
- History of type I or type II diabetes mellitus for more than 3 years
- History of upper gastrointestinal symptoms consistent with diabetic gastroparesis
- Hemoglobin A1c < 9.5%
- Delayed gastric emptying
Key exclusion criteria (7 listed)
- Abnormal endoscopy finding that can explain the presence of gastroparesis symptoms
- Medical conditions affecting gastric emptying
- A clinically significant medical condition that would interfere with the patient completing the trial
- Clinically significant abnormal creatinine level
- Known allergies to the same class of drug and/or allergies to eggs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tegaserod | Drug | – |
Primary outcome
Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET)
5 secondary outcomes
Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying
Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort
Volume and symptomatic response to a gastric satiety drink test (GSDT)
Electrogastrography (EGG)
The safety and tolerability of tegaserod
Results and safety
The study was stopped early (reason given: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceutical Corporation study chair
NPC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegaserod in people with Gastroparesis and Diabetes, run by Novartis at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2012.